FDA label 10212c14-bab2-4c85-8074-b525f3189185

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
4dbcc75e-8d36-4348-897c-72d90bb4dcc7
SPL ID
10212c14-bab2-4c85-8074-b525f3189185
Version
3
Effective date
2018-05-30
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:47:56

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Allergy alert Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics Do not use for more than 7 days unless directed by a dentist or physician When using this product do not exceed recommended dosage avoid contact with eyes localized allergic reactions may occur after prolonged or repeated use Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days swelling, rash or fever develops irritation, pain or redness persists or worsens Keep out of reach of children. If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.